CLN-049 Advances to Registrational Phase 2 Study in Relapsed/Refractory AML
CLN-049 advances to registrational Phase 2 study in relapsed/refractory AML following FDA's End-of-Phase 1 meeting with Cullinan Therapeutics.
The Genetics Are Global. Your Enrollment Plan Isn’t.
A landmark Lancet Neurology study exposes the operational gap in Parkinson's trials: ancestry-based biomarker screening built for European cohorts...
Atea’s Bemnifosbuvir/Ruzasvir Meets Endpoints in Phase 3 Hepatitis C Trial
Atea's bemnifosbuvir/ruzasvir achieved non-inferiority in Phase 3 Hepatitis C trial, offering eight-week treatment for non-cirrhotic patients versus twelve week
Long COVID’s Phase 3 Reckoning: What STIMULATE-ICP Reveals About Designing Trials for Diseases Medicine Can’t Yet Explain
STIMULATE-ICP's cluster-randomized Phase 3 design for Long COVID exposes a fundamental tension in trial methodology: how do you randomize...
The FDA Just Handed Industry a Rulebook on AI in Trials. Now Comes the Hard Part.
FDA and EMA published coordinated AI frameworks in 2025-2026, but sponsor comment letters reveal the real debate: do these...
ICH E6(R3) Redistributes Data Governance Accountability Between Sponsors and Sites
ICH E6(R3) redistributes data governance accountability between sponsors and sites, formalizing joint responsibility for trial data integrity.
SaaS Clinical Trial Software Market Projected for 17.14% Annual Growth
SaaS clinical trial software market projected for 17.14% annual growth, democratizing access to research infrastructure for smaller sites.
Capricor’s Deramiocel Briefing Is a Masterclass in How Not to Define an Endpoint
FDA's July 27 briefing document for Deramiocel (BLA 125842) contradicts Capricor's Phase 3 efficacy claims ahead of tomorrow's AdCom...
Pacira Completes Manufacturing Transition in PCRX-201 Phase 2 Trial
Pacira completes manufacturing transition in PCRX-201 Phase 2 trial without enrollment delays, using commercial process aligned with registration plans.
Akeso Doses First Patient in AK138D1 + Ivonescimab Phase Ib/II Lung Cancer Study
Akeso doses first patient in AK138D1 + ivonescimab Phase Ib/II lung cancer study combining HER3 ADC with PD-1/VEGF bispecific...